BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA ANGIOGRAPHIC CATHETERS

    MDR report key: 2093253 · Received April 14, 2011

    Report

    Report Number
    1628221-2011-00023
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THREE USED SUSPECT DEVICES WERE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE CUSTOMER DID NOT PROVIDE ANY INFO AS TO IF THIS WAS THE INITIAL USE OF THE DEVICE. UPON VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. THE FIRST UNIT HAD TWO KINKS IN THE CATHETER BODY. THE SECOND UNIT HAD SIX KINKS IN THE CATHETER BODY. THE THIRD UNIT HAD FIFTEEN KINKS IN THE CATHETER BODY. NO EVIDENCE OF CLINICAL USE WAS FOUND IN ANY OF THE RETURNED DEVICES. ALL THREE UNITS WERE INSPECTED VISUALLY AND UNDER MAGNIFICATION. NO ANOMALIES WERE FOUND. UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. NO CONCLUSION CAN BE DRAWN. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED. RESULTS: UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A STENTING PROCEDURE OF AN ABDOMINAL AORTIC ANEURYSM, THE CATHETER GOT STUCK WHILE ATTEMPTING TO REPOSITION THE DEVICE. WHEN THE CATHETER WAS REMOVED, SEVERAL KINKS WERE OBSERVED. THE CUSTOMER REPORTED THAT THIS OCCURRED WITH THREE SEPARATE CATHETERS. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF THREE REPORTS FOR THIS COMPLAINT: 1628221-2011-00022, 1628221-2011-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E180265

    Patients

    Seq Age Sex Outcome Treatment
    1 HEPARINIZED SALINE| LUNDERQUIST EXTRA STIFF GUIDE WIRE| TERUMO ANGLED HYDROPHILIC GUIDE WIRE